Parenteral preparation mixing

One of the most important processes involved in the scale-up of liquid parenteral preparations is mixing (1). For liquids, mixing can be defined as a... 

One of the most important processes involved in the scale-up of liquid parenteral preparations is mixing [1]. For liquids, mixing can be defined as a transport process that occurs simultaneously in three different scales, during which one substance (solute) achieves a uniform concentration in another substance (solvent). On a large, visible scale, mixing occurs by bulk diffusion, in which the elements are blended by the pumping action of the mixer s impeller. On the microscopic scale, elements that are in proximity are blended by eddy currents, and they 43... 

An example of the second method of parenteral suspension preparation is testosterone suspension. Here, the vehicle is prepared and sterile-filtered. The testosterone is dissolved separately in acetone and sterile-filtered. The testosterone-acetone solution is aseptically added to the sterile vehicle, causing the testosterone to crystallize. The resulting suspension is then diluted with sterile vehicle, mixed, the crystals allowed to settle, and the supernatant solution siphoned off. This procedure is repeated several times until all the acetone has been removed. The suspension is then brought to volume and filled in the normal manner. 

IV Do not administer undiluted potassium - Potassium preparations must be diluted with suitable large volume parenteral solutions, mixed well and given by slow IV infusion. 

Intensol preparation Mix with liquid or semisolid food such as water, juices, soda, applesauce, and puddings. Consume the entire amount immediately. Do not store. Parenteral ... 

Physicochemical incompatibilities are of particular concern when parenteral administration is planned. For example, certain insulin preparations should not be mixed. Similarly, the simultaneous administration of antacids or products high in metal content may compromise the absorption of many drugs in the intestine, eg, tetracyclines. The package insert and the Handbook on Injectable Drugs (see References) are good sources for this information. 

Aminoglycosides are poorly absorbed from the gastrointestinal tract, so when used systemically they must be given parenterally. Note that penicillins or cephalosporins can inactivate aminoglycosides if mixed together in the same solution fiar injection or fiar topical application each drug must be administered separately. If topical fortified cefazolin and fortified tobramycin are used to treat a corneal ulcer, each should be prepared and administered in a separate bottle. 

From the point of view of water purification, one of tl earliest applications of MF is still the most important sterile filtration. Bacteria can be removed from drinking water, solutions for intravenous or parenteral injection, heat-sensitive liquid foods, and so on by MF. The earliest MF membranes were prepared from cellulose nitrate or from mixed acetate and nitrate esters of cellulose. 

Variations in assay results can be avoided by the preparation of homogeneous, well-mixed, or non-settling fine particle suspensions (size 1-10 pm). Particle size reduction results in slow, more uniform settling rates. The bioavailability of drugs is improved by reducing the size of suspension particles. Furthermore, drug particles smaller than 20 pm produce less pain and tissue irritation when injected parenterally. However, fine particles may have a deleterious effect on chemical stability because of their high dissolution rate. 

The drug concentration in a parenteral suspension can influence the plasma concentration profile. When different concentrations of amoxicillin (100 and 200mg/ml) in aqueous suspensions of amoxicillin trihydrate were administered intramuscularly at the same site and same dose level (lOmg/kg) to horses, the preparation of lower concentration (10%) provided relatively better absorption and a more consistent plasma concentration profile. Intramuscular injection of amoxicillin trihydrate (15% in a mixed oil base) in the neck (10 cm behind the ear) of pigs produced two peaks, 1.7 and 0.8pg/ml at 1.3 and 6.6 h, respectively, rather than a single peak in the plasma concentration profile and an eight-fold longer mean residence time of the antibiotic than a preparation of the same... 

Included in the FDA Inactive Ingredients Guide (IM, IV, and SC injections ophthalmic, otic, and topical preparations). Included in nonparenteral and parenteral medicines licensed in the UK. In the UK, the use of thimerosal in cosmetics is limited to 0.003% w/w (calculated as mercury) as a preservative in shampoos and hair-creams, which contain nonionic emulsifiers that would render other preservatives ineffective. The total permitted concentration (calculated as mercury) when mixed with other mercury compounds is 0.007% w/w. Included in the Canadian List of Acceptable Non-medicinal Ingredients. 

Liquid formulations should be prepared in an area that Is as clean as possible. Water for parenteral products should be of pharmacopoeial Water for Injection quality. Mixing vessels and other equipment should be cleaned and disinfected. It is normal for these areas to be provided with filtered air from HEPA fllteis of somewhat lower efficiencies than those providing protection to aseptic filling rooms. Sterilization of liquid products should be by filtration through... 

The water used for preparing parenteral solutions needs to meet USP requirements for water for injection. These requirements include bacterial endotoxins no greater than 0.25 eu/mL, total organic content less than 500 ppb, and a conductivity of 1.3 iS/cm. Water for injection is prepared by distillation or a two-stage RO process. A typical process to produce water for injection consists of multimedia filtration, softener, activated carbon, 1-5 qm preflltration, UV treatment, two-stage RO, mixed DI, UV, and sterile filtration. 

Preparing parenteral nutrition from components (several additions, mixing large volumes, good growth medium) ... 

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